MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® PLASTIC NRFIT¿ SYRINGE; PISTON SYRINGE

Model Number	400174
Medical Device Problem Codes	Defective Component (2292); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd® plastic nrfit¿ syringe was with or without luerlock.The following information was provided by the initial reporter, translated from dutch to english: we have found that for item number 400174 with lot number 1041220, there are products with and without luerlock.
Additional Manufacturer Narrative
Investigation summary: eighty-three samples and five photos were provided to our quality team for investigation.Through visual inspection, it was observed that nineteen sample had 10ml luer lock standard barrel instead of 10ml nrfit lock barrel.Potential root cause for the mixed product defect is associated with inadequate line clearance on the marking machinery.A corrective action project was opened to further investigate these defect.Manufacturing personnel will be notified of this incident and additional training will be provided.A device history record review was completed for provided lot number 1041220.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation with the samples analysis the symptom reported is confirmed.
Event or Problem Description
It was reported that the bd® plastic nrfit¿ syringe was with or without luerlock.The following information was provided by the initial reporter, translated from dutch to english: we have found that for item number 400174 with lot number 1041220 there are products with and without luerlock.
Additional Manufacturer Narrative
(b)(4) follow up report #2 for correction.The event/product problem was incorrect in the initial mdr.Correct event/product problem is mixed product / lots.Annex a code was incorrect in the initial mdr.Annex a code should be a2101 - device markings / labeling problem.
Event or Problem Description
No additional information was provided.

• Brand Name: BD® PLASTIC NRFIT¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15395696
• Report Number: 1213809-2022-00552
• Device Sequence Number: 20383052
• Product Code: QEH
• UDI-Device Identifier: 00382904001742
• UDI-Public: (01)00382904001742(11)211111(17)260430(10)1041220
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 400174
• Device Catalogue Number: 400174
• Device Lot Number: 1041220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/13/2024
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/28/2022; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown